Alzheimer's, the Drug Agency gives a glimmer of hope that treatment for the early stages of the disease will be OK in Italia

The last word had not yet been spoken: after the Italian Medicines Agency's (AIFA) Scientific and Economic Commission (CSE) ordered a halt in March on the authorisation of the two new monoclonal antibodies donanemab and lecanemab - already approved by the regulatory agencies Fda (USA) and Ema (European Union) for the treatment of early-stage or early-stage Alzheimer's disease - the Italian Medicines Agency's board of directors decided to keep the dossier open. It has done so by calling on the one hand the scientific societies of neurologists and on the other the patients' associations. And in the latter case - as the Agency itself points out - 'this is the first time, since the installation of the AIFA's post-reform board of directors, that patients' associations have been invited to a hearing, an option that is also expressly provided for in the regulation on the organisation and functioning of the board'. An initiative that 'forms part of the broader framework of the policies of participation and active listening to stakeholders that Aifa is promoting, with the aim of enhancing their contribution to the improvement of pharmaceutical assistance,' the body headed by Robert Nisticò further emphasised.

The game - in terms of health, social and health costs, and sustainability for the National Health Service - is one to shake one's wrists and more than 'justifies' the greatest possible involvement of experts and patients: Italia has 1.2 million people with dementia - for about 4 million caregivers - of whom 700 thousand have Alzheimer's disease, while about 800-900 thousand have mild cognitive impairment and of these about 40 per cent will develop the disease. Early intervention is a major challenge. The knot to be unravelled is 'how': taking into account the eligible population - net of the necessary criteria of safety and optimal management of the patient in the presence of relevant side effects - the organisational quality of the centres that belong to the network of the so-called Cdcd, and the still stellar costs that each administration entails. In all likelihood, the opening up of the drugs' reimbursability by the National Health Service will pass through the definition of a, at least initially, very restricted patient population.

Meanwhile, neurologists applaud the initiative. Speaking for them all is Mauro Zappia, president of the Italian Society of Neurology (Sin), who together with his colleagues Pasquale Palumbo (Society of Hospital Neurological Sciences-Sno) and Marco Bozzali (Italian Society of Dementia Neurology -Sindem), brought to Aifa's hearing 'the voice of the entire Italian neurological community in the institutional debate on one of the most relevant issues in the current therapeutic landscape', namely the evaluation of anti-amyloid drugs for the early stages of Alzheimer's. For the experts, Aifa's openness to dialogue - 'also in the light of the evolution of scientific evidence and the comparison with the clinical community and patients' associations - is a relevant signal in a field characterised by high complexity and therapeutic innovation'. "Alzheimer's therapies open up new perspectives and require a rigorous approach in the assessment of their clinical impact," says Aifa president Mario Zappia. "It is therefore positive that the decision-making process maintains a dynamic character and is based on the analysis of all available data

The scientific societies identify four fundamental pillars on which the introduction of these therapies with controlled reimbursability must be based, guaranteeing economic sustainability for public health: rigorous evaluation of the benefit-risk profile; stringent eligibility criteria for patients; provision in highly qualified centres and periodic monitoring; sustainability and appropriateness of use.